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A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)

An Open-label, Multicenter, Phase 2 Follow-on Study for Second Eye Treatment of Patients Previously Treated With a Recombinant Adeno-associated Virus Vector (AAV5 hRKp.RPGR) for Gene Therapy of Adults and Children With X-linked Retinitis Pigmentosa Owing to Defects in Retinitis Pigmentosa GTPase Regulator (RPGR)

NCT06646289•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and tolerability of subretinal delivery of Adeno-associated Virus Vector (AAV5 hRKp.RPGR) gene therapy in adults and children with X-linked retinitis pigmentosa.

Eligibility

Age

5 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Have been treated with AAV5-hRKp.RPGR in study MGT009 and have completed or is currently enrolled in Study MGT010
•Must sign an informed consent form indicating that they understand the purpose and procedures of the study and is willing to participate in the study
•Willing to adhere to the protocol and long-term follow-up

Locations (3)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, United States

Moorfields Eye Hospital

London, United Kingdom

Key Dates

Start Date

October 10, 2024

Primary Completion Date

October 24, 2030

Completion Date

October 24, 2030

Last Updated

March 13, 2026

Enrollment

ACTUAL participants

Conditions

X-Linked Retinitis Pigmentosa

Interventions

AAV5-hRKp.RPGR

BIOLOGICAL

No intervention (Follow-Up assessment)

OTHER

A Phase 2 Open-label Study to Evaluate the Safety of Laruparetigene Zovaparvovec Administered Bilaterally in Male Participants With X-Linked Retinitis Pigmentosa

NCT07174726

X-Linked Retinitis Pigmentosa (XLRP)

View study

RECRUITINGPHASE1/PHASE2

Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa

NCT06492850

X-Linked Retinitis Pigmentosa (XLRP)

View study

ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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